ECG electrode connector

ABSTRACT

Disclosed is an ECG electrode lead wire connector which provides improved electrical and mechanical coupling of the ECG electrode press stud to the lead wire and is suitable for use during imaging procedures such as, without limitation, CT scans or MRI. The connector assembly includes a housing having. An engagement member is pivotably disposed within the housing to retain the connector on an ECG electrode fixed to a patient&#39;s body, an arcuate stiffener is deposed between the engagement member and a pivot member and a radiolucent resilient member configured to bias the engagement member.

BACKGROUND

1. Technical Field

The present disclosure relates to biomedical electrodes, and inparticular, to a radiolucent biomedical electrode connector andradiolucent lead wires for performing biomedical monitoring of a patentduring imaging procedures.

2. Background of Related Art

Electrocardiograph (ECG) monitors are widely used to obtain medical(i.e. biopotential) signals containing information indicative of theelectrical activity associated with the heart and pulmonary system. Toobtain medical signals, ECG electrodes are applied to the skin of apatient in various locations. The electrodes, after being positioned onthe patient, connect to an ECG monitor by a set of ECG lead wires. Thedistal end of the ECG lead wire, or portion closest to the patient, mayinclude a connector which is adapted to operably connect to theelectrode to receive medical signals from the body. The proximal end ofthe ECG lead set is operably coupled to the ECG monitor and supplies themedical signals received from the body to the ECG monitor.

A typical ECG electrode assembly may include an electrically conductivelayer and a backing layer, the assembly having a patient contact sideand a connector side. The contact side of the electrode pad may includebiocompatible conductive gel or adhesive for affixing the electrode to apatient's body for facilitating an appropriate electrical connectionbetween a patient's body and the electrode assembly. The connector sideof the pad may incorporate a metallic press stud having a bulbousprofile for coupling the electrode pad to the ECG lead wire. In use, theclinician removes a protective covering from the electrode side toexpose the gel or adhesive, affixes the electrode pad to the patient'sbody, and attaches the appropriate ECG lead wire connector to the pressstud by pressing or “snapping” the lead wire connector onto the bulbouspress stud to achieve mechanical and electrical coupling of theelectrode and lead wire. Alternatively, ECG connectors that engage viamanipulation of a lever or other mechanical locking device may beemployed. After use, a clinician then removes the ECG lead wireconnector from the pad by pulling or “unsnapping” the connector from thepad or by releasing the lever or other locking mechanism.

Placement of the electrodes on a patient has been established by medicalprotocols. A common protocol requires the placement of the electrodes ina 5-lead configuration: one electrode adjacent each clavicle bone on theupper chest and a third electrode adjacent the patient's lower leftabdomen, a fourth electrode adjacent the sternum, and a fifth electrodeon the patient's lower right abdomen.

During certain procedures it may be necessary to monitor biological(e.g., ECG) parameters of a patient that is undergoing imaging, such asCT-scan or MRI. Use of conventional ECG connectors and lead wire setstypically associated therewith may have drawbacks in these applications,since they tend to interfere with the imaging systems. In one example,certain components of the ECG connectors and/or lead wires may bedetected by the imaging apparatus and consequently may obfuscate thevisual images upon which clinicians and surgeons rely. In anotherexample, ferrous and/or magnetic components commonly found in ECGconnectors, such as in springs and clips, may be potentially hazardouswhen used within the intense magnetic field of an MRI scanner.

SUMMARY

In an embodiment in accordance with the present disclosure, there isprovided an ECG connector assembly, comprising a housing having aninterior recessed surface. The interior recessed surface has disposedtherein an opening dimensioned to operably receive the press stud of anECG electrode pad. A radiolucent conductor is disposed on at least aportion of the interior recessed surface, and a radiolucent lead wireconductor extends from a proximal end of the housing and is operablycoupled to the radiolucent conductor. The ECG connector assemblyincludes an engagement member pivotably disposed upon the interiorrecessed surface and having an engaging face and a pivot. The engagementmember is pivotable between a first position whereby the engaging faceis closer to a top portion of the opening and a second position wherebyengaging face is further from a top portion of the opening. Aradiolucent resilient member disposed within the housing is configuredto bias the engagement member towards the first position.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scales. In thedrawing, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. Various embodiments of the present disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 is an exploded view of a conventional ECG electrode connector;

FIG. 2 is a schematic diagram of the conventional ECG electrodeconnector of FIG. 12A;

FIG. 3A is a view of an embodiment of a radiolucent ECG electrodeconnector in an engaged configuration in accordance with the presentdisclosure;

FIG. 3B is a view of the FIG. 3A embodiment in a disengagedconfiguration in accordance with the present disclosure;

FIG. 3C is a detail view of a press stud opening of the FIG. 3Aembodiment of a radiolucent ECG electrode connector in accordance withthe present disclosure

FIG. 4A is a view of another embodiment of a radiolucent ECG electrodeconnector in an engaged configuration in accordance with the presentdisclosure;

FIG. 4B is a view of the FIG. 4A embodiment in a disengagedconfiguration in accordance with the present disclosure; and

FIG. 5 is a view of another embodiment of a radiolucent ECG electrodeconnector in accordance with the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

This invention is not limited in its application to the details ofconstruction and the arrangement of components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced or of being carriedout in various ways. Also, the phraseology and terminology used hereinis for the purpose of description and should not be regarded aslimiting. The use of “including,” “comprising,” “having,” “continuing,”or “involving” and variations thereof herein, is meant to encompass theitems listed thereafter and equivalents thereof as well as additionalitems.

Particular embodiments of the present disclosure are describedhereinbelow with reference to the accompanying drawings; however, thedisclosed embodiments are merely examples of the disclosure, which maybe embodied in various forms. Well-known functions or constructions andrepetitive matter are not described in detail to avoid obscuring thepresent disclosure in unnecessary or redundant detail. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one skilled in the art to variouslyemploy the present disclosure in virtually any appropriately detailedstructure.

In the drawings and in the descriptions that follow, the term“proximal,” as is traditional, shall refer to the end of the instrumentthat is closer to a user, while the term “distal” shall refer to the endthat is farther from a user. In addition, as used herein, termsreferencing orientation, e.g., “top”, “bottom”, “up”, “down”, “left”,“right”, “clockwise”, “counterclockwise”, and the like, are used forillustrative purposes with reference to the figures and features showntherein. Embodiments in accordance with the present disclosure may bepracticed in any orientation without limitation.

The present invention is directed to an electrode connector suitable foruse during patient imaging, such as during a CT-scan or MRI. Commonlyavailable electrode connectors have components which may be detected onthe image and/or may become dangerous when exposed to a particularfield, such as a magnetic field.

One embodiment of a conventional electrode connector 1320 is shown inFIG. 1 and FIG. 2 which includes a housing 1322 having an upper member1324 and a lower member 1326, and defining an internal cavity 1328therebetween. Housing 1322 is fabricated from a non-conducting material,e.g., an injection molded polymer which electrically insulates thesubject from the conductive element(s) therewithin. Upper member 1324and lower member 1326 are separate components attached to each other byany suitable method of bonding, such as without limitation, adhesive,ultrasonic welding, or heat welding. Upper member 1324 and lower member1326 form a non-conductive element of the housing 1322.

Housing 1322 of the conventional electrode connector includes a leadwire terminal 1330 which is electrically connected to a respective endof lead wire 1304 by any suitable method of connection, includingwithout limitation, crimping, soldering, or welding. Lead wire terminal1330 is formed of a conductive material, typically a metal such asstainless steel. Housing 1322 supports a contact member 1332 also formedof a conductive material that is electrically connected to a lead wire.In one embodiment, the lead wire is formed of a conductive metals suchas tinned copper. In another embodiment, the conductive material of thecontact member is a metal such as stainless steel. Contact member 1332and lead wire terminal 1330 may be integrally formed. Contact member1332 defines a contact opening 1334 formed therein and in communicationwith internal cavity 1328 of housing 1322. Contact opening 1334 includesfirst contact opening portion 1334 a and second contact opening portion1334 b. First contact opening portion 1334 a defines an internaldimension or diameter which is greater than the corresponding internaldimension or diameter of second contact opening portion 1334 b.

Housing 1322 of conventional electrode connector further includes alever 1340 pivotably connected thereto. Lever 1340 includes an actuatingend 1336. Lever 1340 is biased to a first position by a biasing member1338, as shown in FIG. 2. Biasing member 1338 is formed of a resilientmetal, such as stainless steel. Lever 1340 includes an engaging region1336 a projecting therefrom so as to extend across first contact openingportion 1334 a of contact opening 1334 when lever 1340 is in the firstposition. In use, lever 1340 is actuatable to a second position whereinengaging region 1336 a thereof does not obstruct or extend across firstcontact opening portion 1334 a of contact opening 1334. For example, aclinician may apply finger pressure to actuating end 1336 that issufficient to overcome the biasing force of biasing member 1338, therebycausing engaging region 1336 a to move to a second position as hereindescribed.

Conventional ECG electrode connector 1320 is adapted for connection to aconventional snap-type biomedical electrode (not explicitly shown). Atypical snap-type biomedical electrode incorporates an electrode flangeor base and male press stud or terminal extending in transverse relationto the electrode base. The male press stud terminal may have a bulboushead whereby an upper portion of the terminal has a greatercross-sectional dimension than a lower portion of the terminal.Accordingly, in use, when lever 1340 of electrode connector 1320 is inthe second position, the head of the male press stud terminal of thesnap-type biomedical electrode may be inserted into first contactopening portion 1334 a of contact opening 1334 and actuating end 1336,and thus, lever 1340, may be released so that biasing member 1338 movesengaging region 1336 a of lever 1340 against the head of the male pressstud (not explicitly shown) to push or force the lower portion of thepress stud into a second contact opening portion 1334 b of contactopening 1334. The biasing force of biasing member 1338 helps to maintainthe press stud within second contact opening portion 1334 b of contactopening 1334 and thus inhibits removal or disconnection of thebiomedical electrode from ECG connector 1320. However, because lead wireterminal 1330, contact member 1332 and biasing member 1338 are metallic,one or more of these components may be detected in the image and/orbecome dangerous when exposed to a magnetic filed.

Accordingly, one aspect of the present invention provides an electrodeconnector which may be used during patient imaging. One embodiment of anECG electrode connector of the present invention is shown in FIGS. 3A,3B, and 3C. In view thereof, and so as not to obscure the presentdisclosure with redundant information, only those features distinct toECG electrode connector 1400 will be described hereinafter.

ECG electrode connector 1400 is configured to facilitate the monitoringof ECG and other biological parameters while the subject patient isundergoing an imaging procedure, such as without limitation, MRI, CT,PET, and the like. Connector 1400 includes a housing 1424 having aninterior recessed surface 1431 that includes an opening 1434 definedtherein that opens to a patient-facing surface of the housing. Opening1434 is dimensioned to accept the insertion of a head of a press stud ofa patient electrode. Housing 1424 may be formed from any suitablenon-conductive material, including polymeric material. The connector1400 includes an engagement member 1436 having an actuation surface1439, which may be a contoured pushbutton, and an engaging face 1437.Engagement member 1436 is pivotable about a pivot 1415 to enable theengaging face 1437 to move from a first position whereby engaging face1437 is closer to a top portion 1425 of opening 1434 and a secondposition whereby engaging face 1437 is further from a top portion 1425of opening 1434. By this arrangement, the bulbous head of a press studthat has been introduced into opening 1434 may be captured in opening1434 between engaging face 1437 and a sidewall of opening 1434.Engagement member 1436 includes a stiffener 1438, that may have anarcuate shape, disposed between engaging face 1437 and pivot 1415.

The interior recessed surface 1431 of housing 1424 includes aradiolucent conductor 1432 that facilitates the conduction of biologicalsignals between a press stud captured within opening 1434 and a leadwire conductor 1477. Radiolucent conductor 1432 may be included withsurface 1431 by any suitable manner, including without limitation, as aconductive coating and/or a conductive material incorporated withinhousing 1424 or associated portions thereof. In some embodiments,radiolucent conductor 1432 may be formed by dispersing conductive carbonpowder over interior recessed surface 1431. The conductive carbon powderis then fused via the application of heat and/or pressure to thepolymeric material that forms interior recessed surface 1431. In someembodiments, radiolucent conductor 1432 may be formed by the applicationof radiolucent conductive ink to interior recessed surface 1431. Inother embodiments, the radiolucent conductor 1432 may comprise a carbonfiber wire fixed to the recessed surface 1431. As shown in FIG. 3C,radiolucent conductor 1432 may extend onto at least a portion of asidewall 1441 of opening 1434.

ECG electrode connector 1400 includes a lead wire 1475 extending from aproximal (e.g., bottom) end thereof. Lead wire 1475 includes an outerinsulator 1476 coaxially disposed about a conductor 1477. Conductor 1477is formed from radiolucent electrically conductive material, such asconductive carbon or conductive carbon monofilament wire. In someembodiments, conductor 1477 is formed from one or more carbon fibers. Adistal portion of the outer insulator is stripped thus exposing a distalportion of conductor 1477′. The exposed portion 1477′ of conductor 1477is operatively joined to radiolucent conductor 1432 of interior recessedsurface 1431. Conductor 1477′ may be joined by any suitable manner,including without limitation a crimping element 1478 and/or byradiolucent electrically conductive adhesive. In some embodiments, theexposed portion 1477′ of conductor 1477 and radiolucent conductor 1432are integrally formed. A strain relief 1479 surrounds a portion of leadwire 1475 where lead wire 1475 exits the housing 1424

A resilient member 1470 biases engagement member 1436 towards a firstposition whereby engaging face 1437 is closer to a top portion 1425 ofopening 1434. Lobed resilient member 1470 is positioned between a recess1428 defined in engagement member 1436 and a saddle 1472 provided byhousing 1424. Resilient member 1470 may be formed from a radiolucentelastomer, including without limitation, silicone. Resilient member 1470may have any shape to provide sufficient force to allow the desiredmovement of the engagement member 1436. The resilient member 1470 mayhave any regular or irregular shape, including circle, square, triangle,and clover. In one, one embodiment, resilient member 1470 is a lobedmember. In the embodiment shown in FIGS. 3A and 3B, lobed resilientmember 1470 includes a three-lobe profile having each lobe evenly spacedat about 120° apart, however, a lobed resilient member 1470 inaccordance with the present disclosure may include fewer than threelobes, or more than three lobes. Additionally or alternatively, lobedresilient member 1470 may include lobes that are not evenly spacedand/or irregularly placed. The resilient member may be solid throughout,or comprise one or more openings. Lobed resilient member 1470 includes acenter opening 1471 defined therein and having a shape that generallycorresponds to the contour of the perimeter (e.g., the lobe profile) oflobed resilient member 1470, and/or that may include one or moreinterior projections 1481. The ratio of the size of opening 1471 to theoverall size of the lobed resilient member 1470 determines, at least inpart, the resiliency of lobed resilient member 1470 and may facilitatetactile feedback to a user during the actuation/compression andrelease/extension of the combination of lobed resilient member 1470 andengagement member 1436. For example, and without limitation, cooperativeinterference between one or more interior projections 1481 as resilientmember 1470 is compressed and/or released may generate one or morevibrations that may, in turn, be sensed as tactile feedback by a user'sfingertip via actuating surface 1439 and/or via housing 1424.

During use, a user may apply force to actuating surface 1439 using,e.g., a fingertip, thereby overcoming the biasing force of resilientmember 1470 to cause engagement member 1436 to rotate slightlycounterclockwise about pivot 1415. In turn, engaging face 1437 movesfurther from a top surface 1425 of opening 1434 which providessufficient clearance to enable the introduction of a bulbous head of apress stud into opening 1434. Once the press stud is inserted intoopening 1434, the user may remove finger pressure from actuating surface1439, whereupon the biasing force of resilient member 1470 causesengagement member 1436 to rotate slightly clockwise about pivot 1415,thereby electromechanically engaging the press stud with a portion ofopening 1434 and thus, electrically coupling the press stud withradiolucent conductor 1432 and conductor 1477.

Yet another embodiment of a radiolucent ECG electrode connector 1500 isshown in FIGS. 4A and 4B. In view thereof, and so as not to obscure thepresent disclosure with redundant information, only those featuresdistinct to ECG electrode connector 1500 will be described hereinafter.Radiolucent electrode connector 1500 includes an engagement member 1536having an actuation surface 1539, which may be a contoured pushbutton,and an engaging face 1537. Engagement member 1536 is pivotable about apivot 1515 to enable the engaging face 1537 to move from a firstposition whereby engaging face 1537 is closer to a top portion 1525 ofopening 1534 and a second position whereby engaging face 1537 is furtherfrom a top portion 1525 of opening 1534. By this arrangement, thebulbous head of a press stud that has been introduced into opening 1534may be captured between engaging face 1537 and opening 1534.

A resilient member 1570 biases engagement member 1536 towards a firstposition whereby engaging face 1537 is closer to a top portion 1525 ofopening 1534. Resilient member 1570 may have any shape to providesufficient force to allow the desired movement of the engagement member1536. The resilient member 1570 may have any regular or irregular shape,including circle, square, triangle, and clover, and may, but need not besolid throughout. In some embodiments resilient member 1570 has agenerally spherical shape. Spherical resilient member 1570 is positionedbetween a recess 1528 defined in engagement member 1536 and a saddle1572 provided by a housing 1524. Spherical resilient member 1570 may beformed from a radiolucent elastomer, including without limitation,silicone. In the embodiment shown in FIGS. 4A and 4B, sphericalresilient member 1470 may include surface or internal features, such aswithout limitation, ribs, voids, and/or textures that may facilitatetactile feedback to a user during the actuation/compression andrelease/extension of the combination of spherical resilient member 1570and engagement member 1536. In some embodiments resilient member 1570may have a generally cylindrical shape, a generally ovoid shape, and/oror a compound shape that may include, e.g., a combination spherical,cylindrical, and/or ovoid shape. In some embodiments, resilient member1570 may be hollow.

FIG. 5 shows in another embodiment of the present invention similar tothe electrode connector shown in FIGS. 3A, 3B, and 3C. In view thereof,and so as not to obscure the present disclosure with redundantinformation, only those features distinct to ECG electrode connector1600 will be described hereinafter. As seen in FIG. 5, opening 1634which is dimensioned to accept the insertion of a head of a press studof a patient electrode is bounded on at least one side by a conductor1677. Conductor 1677 may have any size and shape as long as at least aportion of the conductor extend into opening 1634 along at least aportion of sidewall 1634. In one embodiment, conductor 1677 extendsthrough opening 1634 to completely cover at least apportion of thecircumference of the opening 1634. Conductor 1677 may be made of aradiolucent conductive material such as a conductive polymer or aconductive carbon. A radiolucent leadwire (not shown) formed of aconductive carbon may be positioned in a passageway 1699 of theconnector housing and joined to conductor 1677. In use, once anelectrode stud is positioned in opening 1634 and engagement member 1636is released, engagement face 1637 captures the electrode stud betweenthe engagement face 1637 and a portion of conductor 1677.

According to one aspect of the invention, the radiolucent electrodeconnectors of the present invention are advantageous because they neednot be removed from a patient before imaging reducing the time requiredto administer often critical procedures. The radiolucent electrodeconnectors of the present invention may also increase patient safety byreducing or eliminating the dangers associated with imaging conventionalelectrode connectors. Moreover, the radiolucent electrode connectors ofthe present invention may allow ECG patient monitoring during imaging.

It will be understood that various modifications, alterations, andimprovements will readily occur to those skilled in the art. Suchmodifications, alterations, and improvements are intended to be part ofthis disclosure, and are intended to be within the spirit and scope ofthe invention. Further variations of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be desirablycombined into many other different systems, instruments andapplications. Various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art, which are also intendedto be encompassed by the following claims. Accordingly, the foregoingdescription and drawing are by way of example only.

What is claimed is:
 1. An ECG connector assembly, comprising: a housinghaving an interior recessed surface having disposed therein an openingdimensioned to operably receiving a press stud of an ECG electrode pad;a radiolucent conductor disposed on at least a portion of the interiorrecessed surface; a radiolucent lead wire conductor extending from aproximal end of the housing and operably coupled to the radiolucentconductor; an engagement member pivotably disposed upon the interiorrecessed surface and having an engaging face and a pivot, wherein theengagement member is pivotable between a first position whereby theengaging face is closer to a top portion of the opening and a secondposition whereby engaging face is further from a top portion of theopening; an arcuate stiffener disposed between an end of the engagingface distal from the pivot and pivot of the engagement member; and aradiolucent resilient member configured to bias the engagement membertowards the first position; wherein the arcuate stiffener is spacedapart from the engaging face.
 2. The ECG connector assembly inaccordance with claim 1, wherein the radiolucent resilient memberincludes a plurality of lobes.
 3. The ECG connector assembly inaccordance with claim 1, wherein the radiolucent resilient memberincludes a center opening defined therein.
 4. The ECG connector assemblyin accordance with claim 1, wherein the radiolucent resilient memberincludes one or more projections that cooperatively interfere togenerate tactile feedback when the engagement member is moved betweenthe first position and the second position.
 5. The ECG connectorassembly in accordance with claim 1, wherein the radiolucent conductorextends onto at least a portion of a sidewall of the opening.
 6. The ECGconnector assembly in accordance with claim 1, wherein the radiolucentconductor is formed from carbon.
 7. The ECG connector assembly inaccordance with claim 1, wherein the radiolucent conductor is formed by:dispersing conductive carbon powder over the interior recessed surface;and fusing the conductive carbon powder to the interior recessedsurface.
 8. The ECG connector assembly in accordance with claim 1,wherein the radiolucent resilient member has a shape selected from thegroup consisting of substantially spherical, substantially cylindrical,or substantially ovoid.
 9. The ECG connector assembly in accordance withclaim 1, wherein the pivotable axis of the engagement member isorthogonal to the interior recessed surface.